IRRAflow continuous irrigation to clear blood and infection inside the head
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
This trial tests whether the IRRAflow system, which continuously irrigates and drains the brain, clears intracranial blood and treats ventriculitis or abscess better than standard external ventricular drains in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06649097 on ClinicalTrials.gov |
What this trial studies
This is a prospective, controlled, post‑market cohort registry comparing the IRRAflow Active Fluid Exchange System to standard external ventricular drains in adults with intracranial hemorrhage, ventriculitis, or intracranial abscess. Eligible patients (age ≥18, radiographic intracranial hemorrhage, indication for active fluid exchange, enrollment within 72 hours of last known well) are enrolled and treated per physician choice with either IRRAflow or standard of care. Radiographic clearance of blood products, device performance, and safety outcomes are collected prospectively and the IRRAS catheter is analyzed when enrollment criteria are met. Additional supportive, medical, or surgical care is provided according to standard practice at the treating center.
Who should consider this trial
Good fit: Adults (≥18) with CT/MRI‑documented intracranial hemorrhage, ventriculitis, or intracranial abscess who are judged by their treating physician to need active fluid exchange and can be enrolled within 72 hours of last known well are appropriate candidates.
Not a fit: Patients with very low neurologic status (GCS ≤5), fixed and dilated pupils, life‑threatening medical conditions, pregnancy, or who are not candidates for active fluid exchange are unlikely to benefit from this device approach.
Why it matters
Potential benefit: If successful, the IRRAflow system could clear blood and infected fluid faster, potentially reducing infections, repeat procedures, and ICU length of stay.
How similar studies have performed: Small case series and single‑center observational reports of automated irrigation/drainage systems like IRRAflow have shown promising radiographic clearance and safety signals, but large randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age \>=18 years of age * Intracranial hemorrhage documented on head CT or MRI scan. * Indication for active fluid exchange evaluated by treating physician. * Signed informed consent obtained by patient or Legal Authorized Representative * Scheduled enrollment and treatment within 72 hours of last known well (LKW) Exclusion criteria: * GCS ≤ 5 * Pregnancy * Fixed and dilated pupil * Life-threatening medical condition
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Kellner — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sukaina Davdani
- Email: Sukaina.Davdani@mountsinai.org
- Phone: (212) 241-2524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.